RecruitingNCT07252765

Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice

Nutritional Management of the Patient With Type 2 Diabetes at Nutritional Risk or With Malnutrition in Clinical Practice. STARLIGHT Study


Sponsor

Outcomes'10

Enrollment

334 participants

Start Date

Nov 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The objective of this observational study is to characterize the patient profile and nutritional treatment patterns of individuals with type 2 diabetes (T2D) or drug-induced diabetes who present with malnutrition, or are at risk of it, and who are prescribed a diabetes-specific oral nutritional supplement (ONS) that is high in calories and protein and contains soluble fiber. Participants will complete a series of questionnaires during visits 1 and 3.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Adult patients diagnosed with type 2 diabetes (T2D) or drug-induced diabetes
  • Patients at nutritional risk according to MUST or presenting malnutrition according to GLIM criteria.
  • Patients requiring a diabetes-specific oral nutritional supplement (ONS) that is high-calorie, high-protein, and contains soluble fiber in real-world clinical practice, and who have been prescribed such a supplement within the previous 7 days.
  • Patients able to provide informed consent and complete the study questionnaires.

Exclusion Criteria5

  • Patients participating in other studies or clinical trials related to malnutrition, or who, in the investigator's opinion, may alter the course of the study.
  • Patients currently receiving or expected to receive other types of nutritional interventions involving supplements (oral or otherwise) or non-conventional feeding methods (e.g., feeding tubes).
  • Patients with a history of metabolic/endocrine diseases (other than diabetes) or any other condition causing liver or kidney failure, defined as ALT \> 3x ULN or eGFR \< 30 ml/min/1.73 m², and according to the investigator's judgment.
  • Patients expected to undergo any surgical intervention or require hospitalization due to a condition unrelated to the study during the study period.
  • Patients with other conditions that, in the investigator's opinion, may interfere with adherence to the intervention or with study procedures.

Locations(12)

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Juan Ramón Jiménez

Huelva, Huelva, Spain

Hospital UniversitarioDoctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital La Princesa

Madrid, Madrid, Spain

Hospital Clínico San Carlos

Madrid, Madrid, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Virgen de la Victoria

Málaga, Malaga, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital Universitario Virgen de la Macarena

Seville, Sevilla, Spain

Hospital La Fe

Valencia, Valencia, Spain

Hospital General de Valencia

Valencia, Valencia, Spain

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NCT07252765


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